Pancreatic Cancer Registry for High Risk Individuals
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Purpose
Studies of pancreatic cancer etiology require a database of detailed personal and family history, with accompanying blood, and when available, fixed and fresh tissue. The aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer. The personal data will be derived by a study questionnaire, which will be completed by each study participant. Blood specimens will be drawn from each participant, a portion of which will be utilized to extract white blood cells for immortalization by Epstein-Barr virus infection. At the time of any surgical tumor resection,tumor and adjacent normal tissue will be requested from the pathologist in the Pathology Department. No additional tissue will be resected beyond that required for surgical management. The questionnaire data can be correlated with the biological information derived from the tissue specimens and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.
| Condition |
|---|
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Pancreatic Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High Risk Individuals |
- Creation of a registry and blood/tissue bank [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.
- Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer. [ Time Frame: 10 years ] [ Designated as safety issue: No ]The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. The epidemiological data will be correlated with the biological information and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. It is anticipated and hypothesized that the knowledge derived will lead to improvements in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
Biospecimen Retention: Samples With DNA
- Peripheral Blood Specimens: Three tubes of blood will be collected from each study participant. Two tubes will be EDTA-whole blood and one tube will be serum. Each tube will contain ~4-5 ml. The whole blood will be frozen and stored. A portion of the blood will be utilized to extract white blood cells that will be immortalized by EBV infection.
- Archived Fixed Tissue Samples: Tissue blocks from surgery performed at CUMC or elsewhere, will be requested after obtaining consent for study participation.
- Fresh Tissue Collection: At the time of surgery for any tumor resection, tumor tissue and adjacent normal tissue will be requested from the Pathology Department. At the time of endoscopy, aspirated fluid or biopsied tissue will be requested. No additional tissue will be resected beyond that required for surgical or endoscopic management. In no circumstance will tissue be obtained solely for the purpose of the study.
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Surgery Patients/High-risk Patients
Patients who have undergone surgery for pancreatic cancer or pre-neoplastic lesions of the pancreas will be accrued to the study. In addition, patients who are determined to be at high-risk for pancreatic cancer (with a significant family history) will also be recruited for study enrollment.
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Detailed Description:
Pancreatic cancer is the fourth leading cause of death resulting from malignancy in both men and women. Approximately 30,500 individuals in the United States will be diagnosed with pancreatic cancer in 2004, and it is expected that 29,100 will die from the disease. The death rate and incidence are virtually identical. It is now known that 4-16% of pancreatic cancers are either inherited or familial. There is still much to be discovered about the etiology of inherited, familial, and sporadic pancreatic cancers. Studies of this type require a database of detailed personal and family history, with accompanying blood, and when available, fixed and fresh tissue. The aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer. The personal data will be derived by a study questionnaire. A portion of the collected white blood cells will be immortalized by EBV infection. At the time of any tumor resection, tumor and adjacent normal tissue will be requested from the Pathology Department. No additional tissue will be resected beyond that required for surgical management. The epidemiological data can be correlated with the biological information and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated and hypothesized that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Individuals who have been diagnosed with pancreatic cancer, s pre-neoplastic lesion in the pancreas, or who have been identified to be at high-risk for developing pancreatic cancer.
Inclusion Criteria:
- The modified clinical Bethesda criteria for HNPCC, which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age <45 years and the adenoma diagnosed at age <40 years); individuals with colon or endometrial cancer diagnosed at <50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at <45 years; or individuals with adenomas diagnosed at <40 years.
- Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BRCA-2 or BRCA-1, hereditary pancreatitis, familial atypical multiple mole melanoma, and others.
- Patients in a family with a genetically determined cancer predisposition syndrome.
- Patients with a personal history of a gastrointestinal malignancy at age <45 years.
- Individuals at high-risk based on personal or family history, but not related to a known pancreatic cancer syndrome include the following: those with a personal history of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family history of two or more individuals with cancer, at least one of which is reported to be a gastrointestinal malignancy; a history of early onset (<50 years) gastrointestinal cancer in the individual or a family member; a history of multiple primary cancers, at least one of which is a gastrointestinal primary, or a family member of an individual meeting this criterion.
Exclusion Criteria:
- Inability to obtain informed consent for study enrollment.
- Under the age of 18 years old.
Contacts and Locations| Contact: Harold Frucht, MD | 212-305-9337 | |
| Contact: Ashley Dikos | ajd2147@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Harold Frucht, MD 212-305-9337 | |
| Contact: Ashley Dikos ajd2147@columbia.edu | |
| Principal Investigator: Harold Frucht, MD | |
| Principal Investigator: | Harold Frucht, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01102556 History of Changes |
| Other Study ID Numbers: | AAAA6154 |
| Study First Received: | April 12, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
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Pancreatic Cancer Pre-Neoplastic Lesions Pancreatic Cancer Surgery |
High-Risk for Pancreatic Cancer Tissue and Blood Bank for Pancreatic Cancer Pancreatic Cancer Questionnaire |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013